FDA to Fertility Doctor: Stop Marketing 3-Parent Baby Technique

The doctor behind the technology that helped birth one of the world’s first 3-parent babies has been told by the FDA that he must stop marketing the experimental procedure.

According to the agency, John Zhang, a New York fertility doctor who helped a Jordanian couple give birth to a baby boy in 2016, had promised the FDA his companies wouldn’t use the technology in the U.S. without the agency’s permission, but they continued to promote it.

The procedure is not approved in the U.S., so a team of American doctors headed by Zhang traveled to Mexico (where the technique is not illegal) to help the Jordanian couple conceive.

According to a medical journal, the procedure occurred at Zhang’s clinic, but the embryo itself was taken to Mexico, where it was implanted. Zhang is under fire by the FDA for skirting the rules by traveling outside of the country to conduct the procedure. The regulatory body says the doctor may not modify embryos and ship them overseas again. [1] [2]

Paul Knoepfler, professor of cell biology at the University of California at Davis, said:

“It does seem like they’re pretty serious about this.” [2]

Zhang’s New Hope Fertility Clinic boasts on its website that it achieved the “first live birth” using the technology. The FDA took exception to that claim, as well others on the site, including a reference to “the first proven treatment for certain genetic disorders.” [1]

Leigh Turner, associate professor of bioethics at the University of Minnesota, said:

“The letter to me is like a shot across the bow. This seems like an area where you’d want to do careful cautious incremental research and not race into the clinic making strong marketing claims.” [2]

The FDA requested that Zhang address the violations immediately.

The experimental technique at the center of the controversy involves removing some of the mother’s DNA from an egg, and leaving the defective DNA behind. The healthy DNA gets inserted into a donor’s egg, which is then fertilized. That way, the baby inherits DNA from both parents as well as the egg donor, though the DNA contribution from the egg donor is very small. [1]

Source: The Guardian

The baby’s mother carries DNA that could have resulted in the child being born with a severe neurological disorder called Leigh syndrome that usually kills within a few years of birth.

In 2016, a panel of U.S. government advisers said in a report that it is ethical to start testing the procedure in pregnancy, but the first studies must follow stringent safety steps. Women at high risk of passing on a severe disease must be included in the research, and only male embryos may be implanted at first, to ensure the edits won’t be passed down to future generations.

Last year, Britain’s fertility regulator gave approval for the “cautious use” of techniques to create 3-parent babies, saying it would start accepting applications from fertility clinics that wish to become licensed to perform the procedure.

The child born with the help of Zhang’s clinic was not the first baby born to 3 parents. In the 1990’s, some children were born using a different technique, and are reportedly doing well.

Julie Fidler is a freelance writer, legal blogger, and the author of Adventures in Holy Matrimony: For Better or the Absolute Worst. She lives in Pennsylvania with her husband and two ridiculously spoiled cats. She occasionally pontificates on her blog.